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Recall Observatory FDA recall evidence

Drug product

TESTOSTERONE CYPIONATE *GS* Oil 200 MG/ML Injectable, Packaged in a multi dose 10ML vial, Formula ID 76681, APS Pharmacy

D-0734-2022

March 23, 2022

Class II

Product summary

Firm
Drug Depot, Inc., dba APS Pharmacy
Event
Event 89808
Status
Terminated
Classification
Class II
Quantity
24 vials
Official record key
drug-enforcement:D-0734-2022

Official wording

Reason: Lack of sterility assurance.

Code information: Lot: 754381 BUD: 8/1/2022

Distribution pattern: Nationwide in the USA including Puerto Rico.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of sterility